The Evaluation of the DIMI RRT System In-Center to Demonstrate Safety and Usability in the Home Environment

Summary

Participation Requirements

Description

Phase 1: Run-in. Duration: 2 weeks. Potential Subjects will undergo dialysis treatments 3 - 5 times per week for up to 2 weeks In-Center. Treatments will be administered by study staff during this phase. Study eligibility will be assessed for both the potential Subject and their Care Partner after c...

Phase 1: Run-in. Duration: 2 weeks. Potential Subjects will undergo dialysis treatments 3 - 5 times per week for up to 2 weeks In-Center. Treatments will be administered by study staff during this phase. Study eligibility will be assessed for both the potential Subject and their Care Partner after completion of the run-in period. Potential subjects and Care Partners who meet all eligibility criteria will be invited to Phase 2. Phase 2: In-Center Treatment. Duration: 6 weeks. Subjects will undergo dialysis treatments 3 - 5 times per week for approximately 6 weeks (for a total of 18 - 30 sessions) In-Center. Treatments will be administered by study staff. Phase 3: Cross-over Period from In-Center to In-Home environment. Duration: 4 weeks. Care Partners will undergo the DIMI training, then perform dialysis treatments on Subjects 3 - 5 times per week for approximately 4 weeks (for a total of 12 - 20 sessions). Treatments will be completed In-Center under the supervision of hemodialysis nurses and at the discretion of the investigator. Phase 4: In-Home Treatment. Duration: 6 weeks. Care Partners will perform dialysis treatments to the Subject 3 - 5 times per week for approximately 6 weeks (for a total of 18 - 30 sessions) in a home environment.

Tracking Information